MannKind completes cohort 1, opens enrollment of cohort 2 for Afrezza study
MannKind announced that cohort 2 of the Afrezza safety and pharmacokinetics study in pediatric patients is now open for enrollment. The first group of individuals participating in the ongoing pediatric study of Afrezza, which included adolescents with type 1 diabetes aged 13-17 years old, was recently completed. The study findings to date support that the single-dose pharmacokinetic, or PK, profile of insulin levels for this age group is consistent with patterns seen in adult patients. In addition, dosing over a one-month period demonstrated a safety profile consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the second cohort of subjects. The second cohort will study Afrezza in children aged 8-12 years and will assess PK, as well as the short-term safety and tolerability of multiple doses of Afrezza.